Treatment with pioglitazone improves triglycerides and high-density lipoprotein (HDL) cholesterol levels in patients with Type 2 diabetes independently of other lipid-lowering and antihyperglycemic medications, report investigators from the PROactive trial.

“Diabetic dyslipidemia is characterized by hypertriglyceridemia, decreased HDL cholesterol levels, and increased small low-density lipoprotein (LDL) cholesterol particles that may contribute to the high level of cardiovascular risk in patients with Type 2 diabetes mellitus,” explain Robert Spanheimer (Takeda Pharmaceuticals North America, Inc., Deerfield, Illinois, USA) and co-researchers.

Pioglitazone Clinical Trial in Macrovascular Events (PROactive).

All PROactive participants had Type 2 diabetes at baseline, of whom 2605 were randomly assigned to treatment with pioglitazone (titrated over 2 months to its maximally approved dosage of 45 mg/day) and 2633 to treatment with placebo in addition to their existing baseline medications. The average follow-up period was 34.5 months.

At baseline, 43% of patients were taking statins, and 10%, 20%, 25%, and 34% were receiving metformin monotherapy, sulfonylurea monotherapy, metformin plus a sulfonylurea, or insulin plus oral agents, respectively.

Following adjustment for baseline medication, the researchers found that triglycerides decreased significantly for all pioglitazone treated individuals by 9.9??”12.3% compared with little change for the placebo group. In addition, HDL cholesterol increased by almost twice as much in pioglitazone- compared with placebo-treated individuals, by 18.1??”20.3% versus 8.1??”11.8%.

However, LDL cholesterol increased moderately in both groups by 5.2??”9.6% in the pioglitazone group and 3.3??”7.6% in the placebo group.

Of note, pioglitazone treatment was associated with a 3.6-kg increase in body weight compared with a 0.4-kg increase in the placebo group.

Edema and heart failure were also more frequently reported in the pioglitazone compared with the placebo group, at 5.7% versus 4.1%. But overall, pioglitazone treatment reduced the relative risk for first cardiovascular event (myocardial infarction, stroke, acute coronary syndrome) by 10% versus placebo.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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